Zimmer Recalls Natural-Knee Flex System Components Due to Discoloration
Zimmer, Inc. is recalling 3,638 units of the Natural-Knee Flex System due to discoloration caused by premature oxidation during storage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to discoloration caused by oxidation during storage, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 3,638 units of the Gender Solutions Natural-Knee Flex System, specifically the N-K FLEX MBACK sizes 0, 1, and 2. The affected item numbers are 00541800000, 00541800001, and 00541800002. The recall covers distribution in the United States (including DC and specific states) and internationally in Canada, Australia, India, Austria, Japan, Czech Republic, South Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
The recall was initiated after a complaint was received regarding a discolored All Poly Tibia component. Root cause analysis determined that the discoloration resulted from free radical oxidation. This oxidation process was advanced prematurely because the machined component was stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions on replacement or return.
The recalled product
- Product
- Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 3,638
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item Numbers 00541800000 00541800001 00541800002
Distribution
Part of a larger recall action
This product is one of 15 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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